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Tuesday, September 3, 2013

THANK YOU @Bob_Ortega #INDIA #CERVICAL CANCER STUDY REVISITED #GYNCSM

Thank you, Bob Ortega. He hasn't let the story disappear. On August 31st, he wrote a follow up about the cervical cancer study in India. It can be found on azcentral.com .

The control group. The women who were not screened. Those who showed up to participate in a research study...... those who were not treated, but monitored... as their cancers progressed. At least 98 of them died. While they were being watched. Bears repeating: as participants in a research study for a treatable and curable cancer. They were observed. In the act of dying. From lack of treatment. For a disease that we know how to treat. Someone has blood on their hands.

I'm not going to rehash everything. It was already determined that the study protocol violated the most basic tenet of medical research. Informed Consent.

I feel like there is a Hatfield v McCoy feud in the making.

On one side, we have the women. And the advocates and the big mouth armchair activists (that would be yours truly) and the whistle blowers and the people who have varying degrees of concern about the ethics of the study. The whole study. An ethical disgrace. For the purpose of this conversation, it's easier to simply point to Informed Consent and the fact the the Office For Human Research Protections found there was improper (or NO) informed consent.

On the other side, the science purists, those who skirt the ethics concerns by sticking to their guns in their ongoing rally cry. Standard of Care. The so called standard of care with regard to cervical cancer screening in India is .... well, nothing. Purists proclaim this makes it acceptable to do nothing within the control group. They did monitor disease progression and bore witness to the deaths of those randomized to the "we treat animal subjects in this country with greater regard" group.

If this is the first time you've stumbled over my outrage, a timeline might be the easiest way to share.

The National Cancer Institute approves funding and study recruitment begins in May of 1998

Dr. Eric Suba questions the ethics of the study in May of 2011 in email to US HHS

In May of 2012, the Office for Human Research Protections asked the hospital in India to respond to allegations of non-compliance with respect to human protection.

In June of 2012, the director of Tata Memorial Hospital in Mumbai responded to the allegations.

In July of 2012, the HHS OHRP determined that there was NO proper informed consent, requested the specific corrective actions that would be taken for each of the determinations. (Note: informed consent must occur prior to enrollment in a trial. How is it possible to implement corrective measures fourteen years AFTER the trial has commenced??)

Apparently, I pissed someone off.... an anonymous comment was left on my original blog post. The February post..... someone left a comment in June, after I criticized ASCO for not saying one word about the ethics question.

About six weeks ago, I learned that the INDIAN government implemented stringent guidelines to protect patients enrolled in clinical trials. Ethics concerns were cited. The regulations went into effect in January. They weren't in the Wall Street Journal until mid July.

The NIH cancelled about 40 trials in India due to an "unstable regulatory environment." The regulatory environment might be (ahem) unstable but it would seem lives are being protected. That's a victory.

And this? Well this is a devoted reporter who is keeping up with the story.....

"We've learned nothing from the deaths..... that we wouldn't have learned had we spared their lives."

~Dr. Eric Suba

From my point of view, if the process was flawed from the get-go .... if there was no proper informed consent.... there can be no justification for anything that resulted from this mess.

In law, it's called fruit of the poisoned tree.

In unethical research, it's the act of feeding the poisoned fruit to those impoverished women who showed up for research. Shame on those who were fully aware women would die, unnecessarily. The thing is, the women had the right to know that, too.

This armchair activist calls bullshit on referring to anyone associated with that study a hero UNLESS they are one of the women who showed up. They are the heroes in this story. The only heroes. And Bob Ortega and especially Dr. Eric Suba for standing up and shining a light on all of this. Informed consent or not, the study was, is and shall forever be, UnEthical.

Since the war of words appears it won't be going away despite everything I outlined, that aforementioned feud between Informed Consent and Standard of Care? There is only one winner. It's called "First Do No Harm."

2 comments:

Amazing how this could have happened. The news you shared in that opening paragraph . . . the entire control group DIED when they could have been helped. Shocking. Disgusting. And mostly, heartbreaking. I just can't believe any researcher would be comfortable with such a study.

This has been a disgrace. I'm grateful for Bob Ortega's stellar reporting and Eric Suba's initial and ongoing whistle blowing. If WE know better, if WE know how to fix something... it's incumbent upon us to do just that....How anyone with a conscious could watch these women die, knowing they could have been successfully treated is something I will NEVER wrap my brain around. Wrong is wrong.